Events

Avis De Sécurité sur Puma, Beatle, Alex & Ibis XP Power Wheelchairs

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Handicare.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2014(04)
  • Date
    2014-02-20
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/puma-beatle-alex-ibis-xp-power-wheelchairs&id=d778f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    Handicare has identified a potential issue with the compact lights on puma, beatle, alex and ibis xp power wheelchairs. the lights might cause overheating and as a result, parts of the compact lights unit could melt or, in extreme situations, ignite. handicare and healthcare 21 have successfully exchanged 33 units of the 87 placed on the irish market. there are 54 units in ireland which cannot be located and require an exchange.
  • Action
    The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected power wheelchairs.  3. If you / your institution have any affected power wheelchairs, please stop using the front and rear light (blinkers can still be used) and contact your local dealer or Healthcare 21.

Device

Puma, Beatle, Alex & Ibis XP Power Wheelchairs
  • Modèle / numéro de série
  • Description du dispositif
    Puma, Beatle, Alex & Ibis XP Power Wheelchairs
  • Manufacturer
    Handicare

Manufacturer

Handicare